(88 days)
The PowerPro™ Battery System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include orthopedic procedures such as osteotomies, small and large bone trauma, orthopedic reconstruction, and total joint replacement, neurosurgical fusion and plating procedures, and medial sternotomy.
The PowerPro Battery System also includes a sterilization case to enclose the rechargeable batteries during sterilization, and also to maintain sterility of the batteries until used.
The PowerPro Battery System is a powered instrument system consisting of various pistol-grip handpieces, universal battery charger, rechargeable batteries and sterilization trays. The handpieces utilize various attachments, such as blades, burs, drills and routers.
This document is a 510(k) premarket notification for the PowerPro™ Battery System. It establishes substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request to create:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance results
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
This document focuses on regulatory approval through substantial equivalence, not on detailed performance studies with acceptance criteria.
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July 20, 2001
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the PowerPro™ Battery System, 510(k) Number
Submitter A.
·
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Laura D. Seneff, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
Trade Name: PowerPro™ Battery System
Common Name: Battery powered surgical instrument and accessories/attachments
Classification Names: Surgical instrument motors and accessories/attachments 878.4820 Sterilization Wrap 880.6850
Proposed Class/Device: II Product Code HAB, FRG
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Summary of Safety and Effectiveness PowerPro™ Battery System 510(k) # July 20, 2001 Page 2 of 2
Predicate/Legally Marketed Devices D.
PowerPro™ Electric System, Linvatec Corporation Advantage™ System, Linvatec Corporation Synthes® Power Drive System, Synthes Allegiance Genesis™ Container System, Allegiance Healthcare Corp.
E. Device Description
The PowerPro Battery System is a powered instrument system consisting of various pistol-grip handpieces, universal battery charger, rechargeable batteries and sterilization trays. The handpieces utilize various attachments, such as blades, burs, drills and routers.
ui Intended Use
The PowerPro™ Battery System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include orthopedic procedures such as osteotomies, small and large bone trauma, orthopedic reconstruction, and total joint replacement, neurosurgical fusion and plating procedures, and medial stemotomy.
The PowerPro Battery System also includes a sterilization case to enclose the rechargeable batteries during sterilization, and also to maintain sterility of the batteries until used.
G. Substantial Equivalence
The PowerPro Battery System is substantially equivalent in design, function and intended use to the predicate devices named above. The PowerPro Battery System does not raise any new safety or effectiveness issues when compared to these similar devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2001
Ms. Laura D. Seneff, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Re: K012320 Trade/Device Name: PowerPro™ Battery System Regulation Number: 878.4820, 880.6850, 882.4360 Regulation Name: Surgical instrument motors and accessories/attachments Sterilization wrap Electric cranial drill motor Regulatory Class: II
Product Code: GEY, FRG, HBC Dated: July 20, 2001 Received: July 23, 2001
Dear Ms. Seneff:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to May 20, 1978, are cance with the provisions of the Federal Food, Drug, devices that have ooon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelore, manel of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations an may oe subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advised that I Driversion that your device complies with other requirements of the Act that I Drinas matures and regulations administered by other Federal agencies. You must or any I catales and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements) and manufacturing practice requirements as set OF N Far 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Laura D. Seneff, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walk, us
Fo
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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July 20, 2001
510(k) Number (if known): Kol2320
Device Name: PowerPro™ Battery System
Indications for Use:
The PowerPro™ Battery System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include orthopedic procedures such as osteotomies, small and large bone trauma, orthopedic reconstruction, and total joint replacement, neurosurgical fusion and plating procedures, and medial sternotomy.
The PowerPro Battery System also includes a sterilization case to enclose the rechargeable batteries during sterilization, and also to maintain sterility of the batteries until used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012320
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.